Zifam Pinnacle, the parent company of Delta Biopharma, has vacancy for a Manager - Quality Assurance (Biologicals) for its upcoming Biologicals manufacturing plant in Yangon, Myanmar.

The plant will be designed specifically for Fill & Finish of Biologicals and will be designed as per EU standards.

The Manager - QA will be responsible for all QA, IPQA, validation, and the entire QMS, in the Biologicals (injectable) manufacturing.

It is expected that the candidate will have UG/PG in life science (such as B Pharm/M Pharm) with at least 12 to 20 years of experience in Quality Assurance of injectables manufacturing, and a thorough knowledge of EU Annex 1, US FDA and similar regulatory requirements. The candidate must have experience in handling Regulatory Audits and managing Audit response.

Responsibilities include, but are not limited to:

Management of Quality Assurance
- Developing and reviewing QA documentation including specifications, SOPs, maintenance, calibration, validation (e.g. Process validation, Cleaning validation etc.) and Product Quality Review (PQR for compliance).




- Developing and implementing QA system for ensuring compliance with regulatory documents and cGMP standards.
- Manage customer complaints.
- Maintenance of the out-of-specification, deviation and change control programs.
- Manage stability monitoring system.
- Manage internal and external audits, regulatory inspections and follow-up actions.
- Review and approve batch production records for intermediates and final biological products.
- Preparation, Execution and Review of Aseptic Process Simulation Protocols and Reports.
- Ensure deviations are adequately investigated and resolved prior t o batch release.
- Conduct investigation o f deviations, OOS/OOT results and quality incidents.
- Ensure timely implementation and effectiveness checks o f CAPA.
- Monitor KPls (deviations, CAPA effectiveness, audit findings, EM trends, etc.).
- Approve supplier qualification, audits and periodic monito

📌 Manager - Quality Assurance (Biologicals) (Baddi)
🏢 Delta Biopharma
📍 Baddi